Home / Recalls / Biocare Medical, LLC / Z-1523-2016

Z-1523-2016 Class III Terminated

Recalled by Biocare Medical, LLC — Concord, CA

Recall Details

Product Type
Devices
Report Date
April 27, 2016
Initiation Date
March 31, 2016
Termination Date
June 20, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
93

Product Description

Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and rabbit IgG primary antibodies on formalin-fixed, paraffin-embedded (FFPE) tissues in an immunohistochemistry (IHC) procedure. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Reason for Recall

Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some few Mach 4 Mouse Probe vials may have been mislabeled as HRP-Polymer.

Distribution Pattern

US Nationwide Distribution in the states of: KS, CA, AZ, OR, FL, KS, CO, MA, KY, NY, IL, OR, MO, NC, TX, PA, OK. SC, TN, PA, TN, GA, and OR. Hungary, Canada, Boliva

Code Information

Lot number 082715; Expiry 01/2017.

Other recalls by Biocare Medical, LLC

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  • Z-1333-2021 Class II — BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model (February 25, 2021)
  • Z-2291-2020 Class II — 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, D (October 10, 2019)
  • Z-2360-2018 Class II — Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure (April 24, 2018)
  • Z-3198-2018 Class II — URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: B (March 15, 2018)
  • Z-0252-2016 Class II — Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME30 (September 8, 2015)
  • Z-1676-2015 Class III — D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA P (May 6, 2015)
  • Z-1535-2015 Class II — CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: (March 17, 2015)
  • Z-0965-2015 Class II — MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usag (December 12, 2014)